Decision to widen access to bortezomib for multiple myeloma and AL amyloidosis

Medicines Decision

PHARMAC is pleased to announce a decision to widen access to bortezomib for patients with multiple myeloma and amyloid light-chain (AL) amyloidosis in conjunction with a change of funded brand of bortezomib through PHARMAC’s annual tender process.

In summary:

  • from 1 March 2020:
    • the Dr Reddy's brand of bortezomib will be funded
    • access to bortezomib will be widened so it can be used at any time in the treatment of multiple myeloma and AL amyloidosis and the number of treatment cycles will no longer be limited
  • from 1 August 2020:
    • the Velcade brand of bortezomib will be delisted
    • the Dr Reddy’s brand of bortezomib will be the only funded brand from 1 August 2020 until 30 June 2022.

As part of this decision, the price and subsidy of the Velcade brand of bortezomib used for extemporaneously compounded preparations (ECP) will be reduced.

Who we think will be most interested

  • People who have multiple myeloma and AL amyloidosis, and their whānau
  • Haematologists/oncologists
  • Hospital pharmacies
  • DHB infusion service providers
  • Patient advocacy groups including Myeloma NZ and Leukaemia & Blood Cancer New Zealand
  • Other organisations with an interest in cancer treatment

Details about this decision

The Special Authority criteria applying to bortezomib in Section B of the Pharmaceutical Schedule will be deleted and replaced with a new set of criteria from 1 March 2020 as follows:

Special Authority for Subsidy

Initial application — (multiple myeloma/amyloidosis) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid without further renewal for applications meeting the following criteria:

Either:

  1. The patient has symptomatic multiple myeloma; or
  2. The patient has symptomatic systemic AL amyloidosis*

 Note: Indications marked with * are unapproved indications.

The Hospital Restrictions applying to bortezomib in Part II of Section H of the Pharmaceutical Schedule will be deleted and replaced with a new set of criteria from 1 March 2020 as follows:

Restricted

Initiation — multiple myeloma/amyloidosis

Either:

  1. The patient has symptomatic multiple myeloma; or
  2. The patient has symptomatic systemic AL amyloidosis *; and

Note: Indications marked with * are unapproved indications.

Dr Reddy's New Zealand Limited’s brand of bortezomib will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 March 2020 as follows:

Chemical and presentation

Brand

Pack Size

Price and subsidy
(ex-man., ex. GST)

Bortezomib inj 3.5 mg vial

Bortezomib - Dr Reddy’s

1

$105.00

Dr Reddy's bortezomib will have Hospital Sole Supply Status, with a DV Limit of 1%, from 1 August 2020 until 30 June 2022.

From 1 March 2020, the current listing of bortezomib 1 mg for ECP in Section B of the Pharmaceutical Schedule, which applies to the Velcade brand, will be amended to change the brand name and price. The new price includes a 4% wastage factor compared to the previous 10%, which better reflects the actual wastage incurred, based on recent PHARMAC analysis. At the same time, a new brand of inj 1 mg for ECP will be listed and will apply to the Dr Reddy’s brand as follows:

Chemical and presentation

Current brand

New Brand

Pack Size

Pharmacode

Price and subsidy
(ex-man., ex. GST)

Bortezomib inj 1 mg for ECP

Baxter

Baxter (Velcade)

1 mg

2383667

$562.34

Bortezomib inj 1 mg for ECP

N/A

Baxter

1 mg

TBC

$31.20

The Velcade brand of bortezomib inj 3.5 mg vial (supplied by Janssen), including the Baxter (Velcade) brand of bortezomib inj 1 mg for ECP, will be delisted from the Pharmaceutical Schedule on 1 August 2020.

Our response to what you told us

We’re really grateful for the time people took to respond to the consultation on proposed widening of funded access. All responses were supportive of the proposal to widen access to bortezomib. A summary of the main theme raised in feedback and our responses to the feedback received is set out below.

Feedback theme Comment
There would be an impact for DHBs due to additional subcutaneous injection administration and pharmaceutical compounding. We acknowledge the potential impacts on DHBs from this decision. Impacts on the health sector, including any additional resource requirements for administration and monitoring, were taken into account when making this decision.

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz; or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 66 00 50.